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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
28/03/2025 Veranova
U.S.A
VERANOVA LP 22442 LISDEXAMFETAMINE DIMESYLATE 2009-01-27 Active II Complete 2020-01-28 2020-01-21
28/03/2025 Noramco
U.S.A
NORAMCO LLC 35645 LISDEXAMFETAMINE DIMESYLATE DRUG SUBSTANCE 2021-11-23 Active II Complete 2021-12-30 2021-11-18